Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03716193 |
Other study ID # |
1804069724 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 17, 2019 |
Est. completion date |
July 2024 |
Study information
Verified date |
January 2024 |
Source |
West Virginia University |
Contact |
Todd Tenenholz, MD |
Phone |
304-293-7227 |
Email |
todd.tenenholz[@]hsc.wvu.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This protocol will take measurements of a variety of tumors involving the skin in order to
assess changes in tumor oxygen from hyperoxygenation therapy and standard cancer-directed
treatments, to demonstrate the clinical feasibility of using in vivo Electron Paramagnetic
Resonance (EPR) Oximetry to obtain clinically useful measurements of tumor oxygen levels from
cancer patients.
Description:
All patients in this study will receive standard of care therapy for their cancer at the
discretion of their treating physician(s). All subjects will be assigned to one of the four
cohorts for which they qualify; there is no randomization and no stratification within the
cohorts.
Cohort 1 - Patients who will receive definitive surgery for a primary malignancy of the skin
Cohort 2 - Patients who will receive definitive radiation (+/- concurrent systemic therapy)
for a primary malignancy of the skin
Cohort 3 - Patients who will receive palliative radiation (+/- concurrent systemic therapy)
for any tumor involving the skin
Cohort 4 - Patients who will receive systemic therapy alone (without radiation) for any tumor
involving the skin
All patients enrolled in this study will undergo two initial measurements of their tumor
oxygen level. On the first day, a small metal disc (less than 1 cm in diameter) called a
SPOTChip will be placed on the surface of the tumor, and held in place using an adhesive. The
patient will then be positioned (lying down or sitting) between a set of two magnets that are
used to measure the oxygen level in the tumor. A small plastic oxygen detector will be placed
on the skin over the tumor. These devices will be used to take a measurement of the tumor's
oxygen level at baseline, then while breathing oxygen through a clear plastic facemask, and
then a final time after the oxygen facemask has been removed.
After the measurements are taken, a small amount (20-50 microliters) of India ink will be
injected into the tumor using a small (28-gauge) needle. The India ink will make a permanent,
dark blue/black colored mark on the tumor. The ink leaves a permanent tattoo in the spot
where it is injected, unless it is physically removed surgically.
The patient will return for another measurement, at least 2 days later. This measurement will
use the India ink that was previously injected (described above) and there will no longer be
a need to use the SPOTChip. For the India ink tumor oxygen measurement a small piece of wire
(called a loop resonator) will be placed over the tumor and held in place using medical honey
and saran wrap or tape. The Investigator will first take a measurement of the tumor's oxygen
level at baseline, then while breathing oxygen through a clear plastic facemask, and then the
mask will be taken the tumor's oxygen level will be measured as it returns to baseline.
Patients who have surgical excision of the tumor (cohort 1) will not have any further
measurements after this point.
Patients who are being treated with radiation therapy (cohorts 2 & 3), will come back for
weekly measurements of the tumor during treatment, followed by one additional measurement one
month after they have completed the course of radiation therapy.
Patients being treated with chemotherapy, immunotherapy, or other systemic therapies without
radiation (cohort 4), will come back for measurements every 3-4 weeks around the time of
their regular infusion, followed by one additional measurement one month after they complete
the course of systemic therapy.
Other known NCT identifiers